Steps for Getting CE Marking

  What is An FDA Form 483?   A Form 483 is a form through which FDA inspector reports and communicates the results of his audit findings to a head of facility. This is a regulatory form, and all findings are bound to auditee and they need to be closed through corrective and preventive action. The observations are usually mentioned in descending order of importance. Some time they are referred with picture of spot or shown to a witness touring with auditor or document is attached to site some observation or noncompliance. Organisation needs to understand before auditor leaves. ·          Gain an understanding of observations noted and assure their accuracy ·          Understand the broader message the agency is sending ·          Identify and discuss any errors in observations ·          Ask questions · ...

  Until today, medical devices were complying with the Medical Device Directive to sell their products in Europe. However major amendments are made in the current MDD to keep up with the growing technological advances in healthcare and medical devices. The new regulations passed by the Council of the European Union is Medical Device Regulations (MDR) 2017/745 that came into force in May 2017 & manufacturers have a transition time of three years until May 2021 to comply with the new regulations. An MDR Gap Analysis is the process of systematically examining a medical device’s clinical evidence portfolio to determine whether it demonstrates conformity with all relevant MDR requirements . It is a crucial first step in developing and maintaining an MDR compliance strategy. Typically, all MDD-MDR transition projects initiate with Gap Assessment. Gap Assessment is a crucial activity during MDR transition & our team with engineering & regulatory expertise are well equipped...

  Clinical Evaluation Report (CER) makes a strong case for your device and its intended use backed by impactful scientific evidence. The aim of a CER is to reduce the risk that the users and patients are exposed to when using a medical device. 6 Requirements of a Clinical Evaluation Report for Medical Device Manufacturers – ·          Scope and plan ·          Identification of pertinent data ·          Appraisal of pertinent data ·          Analysis of the clinical data ·          Finalize the report ·          Physician Review & Approval   After data analysis, the evaluation report should summarize the data analysis. This report should provide strong clinical evidence for conformity assessment so the device can be app...

  Manufacturers are expected to follow the quality system requirements described in FDA 21 CFR part 820 This document guides to govern the design, manufacture, packaging, labelling, storage, installation, and servicing of medical devices intended for human use. The requirements in 21 CFR Part 820 are meant to ensure the safety and efficacy of medical devices sold in the US marketplace. FDA conducts regular inspections of medical device manufacturers to ensure compliance with these regulations. The inspection process, known as the Quality System Inspection Technique (QSIT), evaluates a company’s internal quality processes to determine whether they are in alignment with or in violation of these regulatory requirements. If any violations are discovered, the inspecting agent from FDA will issue in the form of 483 Inspectional Observations, Warning Letters what is applicable   Here are the most common mistakes companies run into with FDA 21 CFR Part 820: 1. ...